The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000254392
Ethics application status
Approved
Date submitted
15/05/2008
Date registered
20/05/2008
Date last updated
6/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Aprepitant for Germ Cell Chemotherapy: A phase II multi-centre trial of a seven day Aprepitant schedule for the prevention of chemotherapy induced nausea and vomiting in patients receiving five day cisplatin-based chemotherapy for germ cell tumours.
Scientific title
Aprepitant for Germ Cell Chemotherapy: A phase II multi-centre trial of a seven day Aprepitant schedule for the prevention of chemotherapy induced nausea and vomiting in patients receiving five day cisplatin-based chemotherapy for germ cell tumours.
Secondary ID [1] 253433 0
ANZUP 0801
Universal Trial Number (UTN)
Trial acronym
Aprepitant for germ cell chemotherapy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of chemotherapy-induced nausea and vomiting for patients being treated for germ cell tumours. 3146 0
Condition category
Condition code
Cancer 3305 3305 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anti-emetic regimen during five day Cisplatin-based chemotherapy Aprepitant 125mg Per Oral (PO) day 1 and 80mg Per Oral (PO) days 2 to 7. 5HT3 Antagonist days 1 to 5 Dexamethasone days 1 to 8.
Intervention code [1] 2883 0
Treatment: Drugs
Comparator / control treatment
Historical control group based on the rate of emesis in the good prognosis germ cell trial conducted by the Australian and New Zealand Germ Cell Group (ANZGCTG) between 1994-2000 (Reference: Toner GC, Stockler MR, Boyer MJ, et al. Comparison of two standard chemotherapy regimens for good-prognosis germ-cell tumours: a randomised trial. Australian and New Zealand Germ Cell Trial Group. Lancet 2001;357(9258):739-45).
Control group
Historical

Outcomes
Primary outcome [1] 4197 0
The primary endpoint of the study is the proportion of patients with no emesis (vomoting or dry retching) during day 1 (1st 24 hour period) and days 1 to 8 (7 X 24 hour periods) of cycle 1 chemotherapy.
Timepoint [1] 4197 0
At day 8 after first day of chemotherapy.
Secondary outcome [1] 7092 0
Proportion of patients with no emesis (vomiting or dry retching) during day 1 to 8 of subsequent cycles of chemotherapy.
Timepoint [1] 7092 0
During day 1 to 8 of subsequent cycles of chemotherapy.
Secondary outcome [2] 7093 0
Proportion of patients achieving the following outcomes during day 1 and day 1 to 8 of cycle 1 and subsequent cycles of chemotherapy.
i) No significant nausea (<2 out of 10)
ii) No use of rescue medication
iii) Complete response (no emesis and no use of rescue medication)
Timepoint [2] 7093 0
During day 1 to 8 of subsequent cycles of chemotherapy.
Secondary outcome [3] 7094 0
Number of emetic episodes on each of days 1 to 8 of chemotherapy of cycle 1 and subsequent cycles of chemotherapy.
Timepoint [3] 7094 0
Daily from day 1 to 8 of subsequent chemotherapy of cycle 1 and subsequent cycles of chemotherapy.
Secondary outcome [4] 7095 0
Compliance with study medication.
Timepoint [4] 7095 0
Daily from day 1 to 8 of subsequent chemotherapy of cycle 1 and subsequent cycles of chemotherapy.

Eligibility
Key inclusion criteria
1. Patient is 18 years or older.
2. Patient has a histologically or cytologically confirmed germ cell tumour.
3. Patient is scheduled to recieve a 5 day Cisplatin (20mg per metre square) based chemotherapy. Ie: Any of: BEP (Cisplatin, Etoposide, Bleomycin: Indiana Regimen); Accelerated BEP (ANZGCTG Regimen); VIP (Cisplatin, Ifosfamide, Etoposide); VeIP (Cisplatin, Ifosamide, Vinblastine); or TIP (Paclitaxel, Ifosfamide, Cisplatin).
4. Patient has a predicted life expectancy of 4 months or more.
5. Patient has an ECOG performance score of 3 or less.
6. Patient is able to read, understand and complete patient diary.
7. Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has vomited in the 24 hours prior to Treatment Day 1.
2. Previous chemotherapy.
3. Patient has a symptomatic metastatic CNS malignancy.
4. Patient has recieved radiation therapy to the abdomen or pelvis in the week prior to treatment, or will recieve radiation therapy to the abdomen or pelvis during days one to eight of treatment.
5. Patient has an active infection (e.g. pneumonia) or any uncontrolled disease except for malignancy (e.g diabetic ketoacidosis, gastrointestinal obstruction) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
6. Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
7. Patient has current evidence of alcohol abuse as determined by the investigator.
8. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
9. Patient has a history of hypersensitivity to Aprepitant, Ondansetron, or Dexamethasone.
10. Patient has previously participated in a study with Aprepitant.
11. Patient has taken any of the following CYP3A4 substrates during the 7 days of treatment day 1: Terfenadine, Cisapride, Astemizole, or Pimozide.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A - No allocation concealment. This is a single-arm nonrandomised trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - Not randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,TAS
Recruitment postcode(s) [1] 678 0
2050, 3690, 7000, 5000, 5042, 3002, 4102, 2137, 3065
Recruitment outside Australia
Country [1] 966 0
New Zealand
State/province [1] 966 0

Funding & Sponsors
Funding source category [1] 3382 0
Other Collaborative groups
Name [1] 3382 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) formerly the Australian and New Zealand Germ Cell Trials Group (ANZGCTG) and Australasian Prostate and Urogenital Cancer Trials Group (APUG)
Address [1] 3382 0
NHMRC Clinical Trial Centre Level 6 Medical Foundation Building 92-94 Parramatta Road Camperdown NSW 2050
Country [1] 3382 0
Australia
Funding source category [2] 269983 0
Commercial sector/Industry
Name [2] 269983 0
MSD Australia
Address [2] 269983 0
Level 4, 66 Waterloo Road
North Ryde NSW 2113
Country [2] 269983 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
NHMRC Clinical Trials Centre Level 6 Medical Foundation Building 92-94 Parramatta Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 3024 0
None
Name [1] 3024 0
Address [1] 3024 0
Country [1] 3024 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5407 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 5407 0
Cancer Institute NSW Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
Ethics committee country [1] 5407 0
Australia
Date submitted for ethics approval [1] 5407 0
Approval date [1] 5407 0
23/07/2008
Ethics approval number [1] 5407 0
2008C/06/056
Ethics committee name [2] 6829 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [2] 6829 0
Smorgon Family Building
St Andrew's Place
East Melbourne VIC 8006
Ethics committee country [2] 6829 0
Australia
Date submitted for ethics approval [2] 6829 0
01/12/2008
Approval date [2] 6829 0
09/02/2009
Ethics approval number [2] 6829 0
08/64
Ethics committee name [3] 6830 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [3] 6830 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [3] 6830 0
Australia
Date submitted for ethics approval [3] 6830 0
16/09/2008
Approval date [3] 6830 0
16/10/2008
Ethics approval number [3] 6830 0
New ethics HREC. Please modify.
Ethics committee name [4] 6831 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [4] 6831 0
St Vincent's Hospital
Melbourne VIC 3065
Ethics committee country [4] 6831 0
Australia
Date submitted for ethics approval [4] 6831 0
01/10/2008
Approval date [4] 6831 0
07/01/2009
Ethics approval number [4] 6831 0
New ethics HREC. Please modify.
Ethics committee name [5] 271946 0
Flinders Clinical Research Ethics Committee
Ethics committee address [5] 271946 0
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [5] 271946 0
Australia
Date submitted for ethics approval [5] 271946 0
Approval date [5] 271946 0
02/03/2009
Ethics approval number [5] 271946 0
307/08
Ethics committee name [6] 271947 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [6] 271947 0
Royal Adelaide Hospital
North Terrace SA 5000
Ethics committee country [6] 271947 0
Australia
Date submitted for ethics approval [6] 271947 0
Approval date [6] 271947 0
27/10/2008
Ethics approval number [6] 271947 0
081015
Ethics committee name [7] 271948 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [7] 271948 0
Office of Research Services
University of Tasmania
Churchill Avenue
Sandy Bay TAS 7005
Ethics committee country [7] 271948 0
Australia
Date submitted for ethics approval [7] 271948 0
Approval date [7] 271948 0
11/08/2009
Ethics approval number [7] 271948 0
H10627
Ethics committee name [8] 271949 0
Princess Alexandra Hospital Human Research Ethics Committee (HREC)
Ethics committee address [8] 271949 0
Human Research Ethics Committee (HREC)
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [8] 271949 0
Australia
Date submitted for ethics approval [8] 271949 0
Approval date [8] 271949 0
03/02/2009
Ethics approval number [8] 271949 0
2008/197

Summary
Brief summary
This is a trial of the drug Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in people being treated for germ cell tumours with cisplatin-based chemotherapy.

Who is it for?
You can join this study if you: - have germ cell cancer that is at early or local, locally advanced or locally recurrent stage - are being treated with cisplatin-based chemotherapy.

Trial details
All participants receive anti-emetic (anti-vomiting or dry retching) treatment with Aprepitant for seven days while they are receiving their first cycle of Cisplatin-based chemotherapy. The study will measure the number of participants with no emesis during day 1 to 8 of chemotherapy. Chemotherapy-induced nausea and vomiting is an unpleasant side effect of chemotherapy for germ cell tumours, and this study hopes to minimise this.
Trial website
www.anzup.org.au
Trial related presentations / publications
D B Thomson, P S Grimison, M D Chatfield, M R Stockler, G C Toner, V Gebski, R A Harrup, C Underhill, G Kichenadasse, N Singhal, A L Boland, A McDonald, I N Olver, Australian and New Zealand Urogenital and Prostate Cancer Trials Group. hase II trial of aprepitant on days 1 to 7 for patients with germ cell tumors having cisplatin on days 1 to 5 [Abstract] J Clin Oncol 29: 2011 (suppl; abstr e19577), ASCO Annual Meeting, Chicago, USA, June 2011 (Presented)

Thomson D B, Grimison P S, Chatfield M, Stockler M R, Toner, G C, Gebski, V., Harrup R A, Boland A L, McDonald A, Olver I, Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Phase 2 trial of aprepitant on days 1-7 for patients with germ cell tumours having cisplatin on days 1-5[Poster] Medical Oncology Group of Australia Annual Scientific Meeting, Adelaide , Australia, 10-12 August 2011 (Presented)

Olver I, Grimison P S, Chatfield M, Stockler M R, Toner, G C, Gebski, V., Harrup R A, Underhill C, Kichenadasse K, Singhal N, Boland A L, McDonald A, Thomson DB, Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Phase 2 trial of aprepitant on days 1-7 for patients with germ cell tumours having cisplatin on days 1-5[ Poster] Multinational Association of Supportive Care in Cancer (MASCC) Symposeum, Athens, Greece, 23-25 June 2011 (Presented)
Public notes

Contacts
Principal investigator
Name 28587 0
Address 28587 0
Country 28587 0
Phone 28587 0
Fax 28587 0
Email 28587 0
Contact person for public queries
Name 11744 0
ANZUP Associate Oncology Program Manager
Address 11744 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 11744 0
Australia
Phone 11744 0
(02) 9562 5000
Fax 11744 0
(02) 9562 5094
Email 11744 0
anzup@ctc.usyd.edu.au
Contact person for scientific queries
Name 2672 0
ANZUP Associate Oncology Program Manager
Address 2672 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 2672 0
Australia
Phone 2672 0
(02) 9562 5000
Fax 2672 0
(02) 9562 5094
Email 2672 0
anzup@ctc.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary